Cryo-surgical systems and methods of using the same

ABSTRACT

A method of preparing a cryo-surgical system for treatment includes accessing a container containing a refrigerant, a delivery tube having a first end configured to be in flow communication with the container and a second end opposite the first end. The system further includes a plurality of flexible finger portions disposed proximate the second end of the delivery tube opposite the first end. A porous applicator bud is disposed proximate the second end of the delivery tube. The porous applicator bud includes a body portion disposed between the plurality of flexible finger portions and a contact surface extending from the plurality of flexible finger portions. An adjustment ring disposed along the delivery tube adjacent to the plurality of flexible finger portions can be used to adjust the size of the contact surface of the porous applicator bud.

CROSS-REFERENCE TO RELATED APPLICATIONS

This application is a divisional application of U.S. patent applicationSer. No. 12/997,056, filed on Mar. 14, 2011, which is a U.S. nationalphase application of PCT/US2009/046989, filed on Jun. 11, 2009, whichclaims priority to U.S. Provisional Application No. 61/060,542, filed onJun. 11, 2008. This application claims the benefit of priority to thesepreviously-filed applications, and the entire contents of thesepreviously-filed applications are incorporated herein by reference.

TECHNICAL FIELD

The present invention relates to a system and method for performinglesion removal, and more particularly, to a cryo-surgical device andmethod of using a cryo-surgical device that enables removal of lesionshaving different sizes.

BACKGROUND

Conventional cryo-surgical systems for removing lesions have fixed sizedbuds. However, different sized buds (i.e. 5 mm and 2 mm) are availableto treat various sized lesions. For professional or Over-The-Counter(OTC) applications, the user is never sure how many treatments will berequired to remove the lesion, or which sized bud will be needed toeffectively treat the lesion. Much of the pain associated with thetreatment of lesions results from the freezing of the lesion, as well asthe freezing of healthy tissue that surrounds the lesion. Accordingly,matching the size of the bud to the lesion to be treated will minimizethe pain associated with the treatment. In addition, due to the viralnature of many lesions, it is recommended that a bud be used for onlyone treatment location.

There are many factors that determine the number of treatments whichwill be needed to remove the lesions in both the professional and OTCmarkets. In the OTC market, the user must purchase a kit where the totalnumber of treatments ranges from 7 to 12, and includes buds and apressurized can containing a sufficient amount of refrigerant toeffectively treat the lesion. Accordingly, the pressurized can with therefrigerant must maintain integrity at high temperatures during theshipping process to retail markets. However, since most OTC kits requirea valve to release the refrigerant during each of the separatetreatments, the valve must withstand the internal pressures of the canat high temperatures and minimize any leaking of the refrigerant fromwithin the can that could reduce the shelf life of the kit. Accordingly,the pressurized can must have sufficient refrigerant to compensate forany normal losses during shipping, and storage during its shelf life,and still deliver the maximum number of treatments up to and includingthe last day of the kit's defined shelf life. To insure this,manufacturers overfill the pressurized can with refrigerant and increasethe pressure within the can. As a result, after utilizing all of theindividual buds provided with the kit for the treatments, any residualpressurized refrigerant remains in the can and presents issues regardingenvironmentally safe disposal, as well as an explosion hazard for theuser during the disposal process.

In light of the above issues, it may therefore be desirable to provide acryo-surgical system capable of match the bud size to the size of atargeted lesion or area of a lesion. It may further be desirable toadjust the bud size of a treatment system to substantially reduce thedamage to healthy tissue adjacent to a targeted lesion or treatment areaof a lesion. It also may be desirable to provide a single-usecryo-surgical treatment for lesions. Further it may be desirable toprovide a system having a configuration to provide for precise treatmentof lesions in substantially hard to reach locations.

SUMMARY

The present teachings may solve one or more of the above-mentionedproblems. Other features and/or advantages may become apparent from thedescription which follows.

In various exemplary embodiments, the present teachings contemplate acryo-surgical system comprising a container containing a refrigerant; adelivery tube having a first end configured to be in flow communicationwith the container and a second end opposite the first end; a pluralityof flexible finger portions disposed proximate a second end of thedelivery tube opposite the first end; an applicator bud having a bodyportion disposed within the plurality of flexible finger portions and acontact surface extending from the plurality of flexible fingerportions; and an adjustment ring disposed along the delivery tubeadjacent to the plurality of flexible finger portions. The contactsurface of the bud may be changeable by adjustment of the adjustmentring.

In various exemplary embodiments, the present teachings also contemplatea method of treating a lesion, the method comprising providing acontainer containing a refrigerant and a delivery tube having a firstend configured to be in flow communication with the container and asecond end opposite the first end, and an applicator bud disposedproximate the second end; adjusting a size of the applicator bud bycompressing a surface of the applicator bud; delivering refrigerant fromthe container to the applicator bud; and applying the applicator bud toa targeted treatment lesion area to freeze the lesion area.

Additional objects and advantages may be set forth in part in thedescription which follows, and in part will be obvious from thedescription, or may be learned by practice of the present teachings.Those objects and advantages will be realized and attained by means ofthe elements and combinations particularly pointed out in the appendedclaims.

It is to be understood that both the foregoing general description andthe following detailed description are exemplary and explanatory onlyand are not restrictive of the present teachings or claims.

BRIEF DESCRIPTION OF THE DRAWINGS

FIG. 1 is a perspective assembly view with some internal componentsshown of an exemplary cryo-surgical system according to the presentinvention;

FIG. 2 is a perspective view, showing some internal features of theexemplary cryo-surgical system of FIG. 1 according to the presentinvention;

FIGS. 3A-3C are perspective views, showing some internal features, ofother exemplary cryo-surgical systems in accordance with the presentinvention;

FIG. 4 is a perspective view, showing some internal features, of yetanother exemplary cryo-surgical system in accordance with the presentinvention;

FIG. 5 is a perspective view of yet another exemplary cryo-surgicalsystem in accordance with the present invention;

FIG. 6 is a cross-sectional view of the cryo-surgical system of FIG. 5;and

FIG. 7 is a cross-sectional view of another exemplary embodiment of acryo-surgical system in accordance with the present invention.

DETAILED DESCRIPTION OF VARIOUS EXEMPLARY EMBODIMENTS

FIG. 1 is a perspective assembly view of an exemplary cryo-surgicalsystem according to the present invention. In FIG. 1, a cryo-surgicalsystem 100 includes a container 110 having an opening portion 112, adelivery tube 120 having a first end 122 configured to be connected tothe container 110, an adjustment ring 130 slideably disposed on thedelivery tube 120, and a bud 140 coupled within a second end 124 of thedelivery tube 120. The opening portion 112 of the container 110 may haveexternal threads that engage internal threads of the first end 122 ofthe delivery tube 120. In an exemplary embodiment, the container 110 maybe configured to contain enough refrigerant for a single-use treatment,wherein the amount of refrigerant for the single-use treatment isdependent upon the size, configuration, and material of the bud 140 inorder to establish a treatment temperature of the bud 140 to beapproximately at least about −27° C., and preferably lower than about−27° C. For example, the container 110 may contain from about 3 ml toabout 4 ml of refrigerant, which may or may not be under substantialpressure. Accordingly, in the exemplary embodiment of FIGS. 1 and 2, novalve is required between the container 110 or the delivery tube 120,thereby reducing costs and maintaining a safe way to provide treatmentof a lesion. Although the container 110 is shown having a substantiallyflask-type configuration, the container 110 may include other shapes toimprove usefulness by the user.

Although not specifically shown, the first end 122 may include aprotrusion to pierce or rupture a sealed surface of the opening portion112 of the container 110. For example, by coupling together thecontainer 110 and the delivery tube 120 using the threaded openingportion 112 and the first end 122, the protrusion may puncture thesealed surface of the opening portion 112 of the container 110, therebyestablishing a fluid connection between the refrigerant within thecontainer 110 and the delivery tube 120, and hence the bud 140.Accordingly, there is no valve system or device required or neededbetween the delivery tube 120 and the container 110 to regulate the flowof refrigerant. However, in some exemplary embodiments, in particulardepending on the type of refrigerant, such as, for example, highpressure, flammable refrigerants, in the container 110, a valvingmechanism may be desirable to and thus the exemplary embodiment withouta valve is non-limiting and exemplary only.

In the exemplary embodiment of FIGS. 1 and 2, the delivery tube 120 maydefine a delivery lumen 121 (shown in dashed lines in FIGS. 1 and 2)having openings 123, 127 at opposite ends to flow the refrigerant fromthe container 110 through the delivery tube 120 and to the bud 140. Inan exemplary embodiment, the lumen 121 may have a cross-section that issmaller than the outer cross-section of the delivery tube 120. However,in alternative configurations, the delivery tube outer cross-section maybe approximately the same size as the cross-section of the deliverylumen. Such an alternative configuration is depicted in the exemplaryembodiment of FIGS. 5-7, described in further detail below.

In another exemplary embodiment, the delivery tube 120 may containporous material or materials to transmit the refrigerant from thecontainer 110 to the bud 140. Accordingly, the porous material(s) withinthe delivery tube 120 may be the same or different from the material(s)that form the bud 140, as detailed below. Moreover, the porousmaterial(s) may be provided along only a portion or portions of thedelivery tube 120. For example, as depicted in the exemplary embodimentof FIG. 3A, the porous material(s) 350 may be provided within the lumen321 at the first and second ends 322 and 324 with a middle portion ofthe delivery tube 320 void of any porous material(s). In the exemplaryembodiments of FIGS. 3A-3B, the various parts of the systems are thesame as are shown and described for the exemplary embodiment of FIGS.1-2, but have been labeled with a 300 series of reference numerals.Alternatively, as depicted in FIG. 3B, only a middle portion of thelumen 321 of the delivery tube 320 may include porous material(s) 350.Those having ordinary skill in the art will appreciate that variouscombinations of the placement of porous materials 350 are consideredwithin the scope of the present teachings, for example, porous material350 may fill the entire lumen 321. In another exemplary embodiment,depicted in FIG. 3C, the porous material(s) 350 may be provided as ahollow tube concentrically disposed within the lumen 321 of the deliverytube 320 such that a hollow pathway may be provided along a length ofthe delivery tube 320 from the container 310 to the bud 340. In FIGS.3A-3C, other components of the cryo-surgical systems are the same asthose shown and as described herein with reference to FIGS. 1 and 2 andtherefore are not specifically described herein.

In exemplary embodiments wherein porous material(s) fill a deliverylumen or are otherwise in contact with the applicator bud, the porousmaterial(s), act as a reservoir to receive the refrigerant and to supplythe bud with refrigerant. As the refrigerant evaporates from the bud,additional refrigerant is supplied from the porous material. In thismanner, a wicking effect is created whereby the porous material feedsthe bud with additional refrigerant as refrigerant from the outersurface of the bud evaporates. The refrigerant received and held by theporous material is predominantly, if not completely, in the liquidstate. Supplying additional liquid refrigerant to the bud allows the budto maintain its cold temperature for a longer period of time. Thisincreases the depth and efficacy of freezing and, therefore, thecryosurgical treatment. This can be particularly useful for single-usecryosurgical devices. For a single-use cryosurgical device, therefrigerant can be discharged and increased duration of treatment may beachieved with exemplary embodiments including porous materials inconjunction with a bud.

Exemplary refrigerants used in accordance with the present inventionpreferably have a boiling point at atmospheric pressure within a rangefrom about 25° C. to about −120° C., for example from about 0° C. toabout −75° C. Suitable refrigerants may include, but are not limited to,halogenated hydrocarbons (i.e., tetrafluoromethane, trifluoromethane,monochlorotrifluoromethane, hexafluoroethane, monobromotrifluoromethane,monochlorodifluoromethane, monochloropentafluorothane,dichlorodifluoromethane, 1,2-dichloro-1,1,2,2-tetrafluoroethane,trichloromonofluoromethane, 1,1,2-trichloro-1,2,2-trifluoromethane and1,1-difluoroethane), propane, n-butane, isobutane, dimethyl ether, andnitrogen. Dimethyl ether and alkanes, such as propane, are preferablefor environmental reasons.

With reference again to FIG. 1, the bud 140 includes a first end portion142 that insertably receives the delivery tube 120, a body portion 144disposed within the second end 124 of the delivery tube 120, and asecond end portion 146 to extend from the second end 124 of the deliverytube 120. Here, the body portion 144 will be frictionally retained bythe delivery tube 120. For example, the delivery tube 120 may comprisefinger portions 125 that flexibly fit around the body portion 144. Thefinger portions 125 may be flexible to permit substantially elasticmovement of the finger portions 125 inwardly and outwardly (i.e., towardand away from the bud 140). The contact surface of the second endportion 146 may have a maximum, uncompressed diameter of about 5 mm, butmay be increased or reduced based upon the size of the lesion to betreated.

The bud 140 is formed of a porous material or materials. For example,the bud 140 is composed of cotton wool, open-celled foams, andpolyolefin or polyester non-woven fabrics. Here, the material(s) of thebud 140 do not react chemically with the refrigerant and has suitablephysical properties throughout the range of temperatures to which thebud 140 is exposed during use, for example, from about 25° C. to about−120° C.

The density of the material(s) is preferably less than about 60 kg/m3,and preferably within a range of about 10 kg/m3 to about 40 kg/m3, andmore preferably within a range of about 12 kg/m3 to about 35 kg/m3, andeven more preferably within a range of about 26 kg/m3 to about 32 kg/m3.The pore size of the bud 140 is preferably within a range of about 5pores/cm to about 50 pores/cm, and preferably within a range of about 20pores/cm to about 40 pores/cm, and more preferably within a range ofabout 30 pores/cm to about 40 pores/cm, and even more preferably withina range of about 27 pores/cm to about 32 pores/cm.

The bud 140 may be formed from suitable foam-type polymer material(s)including, but not limited to, polyesters, polyethers, polyurethanes,polyethylene, polypropylene, phenolic resins, polystyrenes and polyvinylchloride resins. and in particular, polyester-based polyurethanes.Preferably, the foam-type material(s) is composed of a polymer that iswettable by the refrigerant, thereby quickly obtaining lower treatmenttemperatures and/or increased effective treatment times. Open-celledfoam materials are preferred.

The bud 140 also may comprise layers of porous materials, for example,layers of differing porous materials.

According to an embodiment of the present invention, the bud 140 mayalso include an internal cavity. When the refrigerant is provided to thebud 140, the foam material(s) is subject to internal pressure from therefrigerant and may be subject to external pressure when pressed againstthe targeted treatment area of the lesion. Accordingly, the wallthickness of the bud 140 should be selected accordingly. In addition,the cavity may be filled, at least in part if not entirely, with asuitable permeable and absorbent solid material or materials. Thematerial(s) modifies and controls the pressure and flow of therefrigerant into the interior cavity of the bud 140 so that the coolingeffect is more uniform and more reproducible. For example, cotton woolmay be placed within the cavity of the bud 140 due to its permeabilityand absorbency. In addition, other materials, including other non-wovenfibrous cellulosic or non-cellulosic materials could also be used. Thepresence of the cotton wool or other permeable material can also improvethe physical strength of the bud 140. The cotton wool or othermaterial(s) provided within the cavity of the bud 140 may fill thecavity in order to make direct contact with the walls of the cavity,thereby providing physical support to the bud 140. This type of bud isdescribed in Jensma, U.S. Pat. No. 6,387,090, which is incorporated byreference herein.

Although not specifically shown, the bud 140 and/or the plurality offinger portions 125 may also include a protective wrapper or cover tomaintain integrity of the system 100. Accordingly, prior to using thesystem 100, the user may remove the wrapper before attaching thedelivery tube 120 to the container 110.

FIG. 2 is a perspective view of the exemplary cryo-surgical system ofFIG. 1 according to the present invention. In FIG. 2, the adjustmentring 130 is positioned toward the second end 124 of the delivery tube120. Here, the adjustment ring 130 includes an internal threaded portion132 which engages external threads of the second end 126 of the deliverytube 120. Since the inner diameter of the adjustment ring 130 is smallerthan the outer diameter of the delivery tube 120, the adjustment ring130 may be slid into position with respect to the finger portions 125.As the adjustment ring 130 is tightened along the external threads ofthe second end 126 of the delivery tube 120, the adjustment ring 130travels toward the finger portions 125. Accordingly, the adjustment ring130 causes the finger portions 125 to close around the body portion 144and second end portion 146 of the bud 140, thereby compressing the bodyportion 144 and the second end portion 146 and reducing a contactsurface of the second end portion 146 of the bud 140. Thus, the contactsurface 146 may be reduced using the adjustment ring 130 to treat arelatively small targeted treatment area of a lesion. Conversely, thecontact surface of the second end portion 146 of the bud 140 may bemaximized by merely tightening the adjustment ring 130 snuggly so as tonot compress the bud 140 using the finger portions 125 in order to treata larger targeted lesion or treatment area of a lesion. As a result, thebud 140 may be adjusted to provide for treatment of relatively large andsmall targeted lesion or treatment areas of a lesion by tightening orloosening the adjustment ring 130.

Alternatively, the adjustment ring 130 may be frictionally fit to thefinger portions 125 such that the internal threads 132 of the adjustmentring 130 and the external threads at the second end 126 of the deliverytube 120 are not necessary in order to compress the bud 140.

In another exemplary embodiment, illustrated in FIG. 4, an adjustmentring 430 having a configuration similar to adjustment ring 130 may beattached to the upper end 424 of the delivery tube 420 proximate fingerportions 425. The adjustment ring 430 may be attached to the deliverytube 420 via a spring 435 (shown underneath the adjustment ring 430 inFIG. 4). When it is desired to increase the size of the bud 440, theadjustment ring 430 may be moved in a direction toward the container410, thereby compressing the spring 435 toward the container andpermitting the adjustment fingers 425 to open outwardly, at leastpartially removing the compression forces from the body portion 444 andsecond end portion 446 of the bud 440. When it is desired to decreasethe size of the bud 440, the adjustment ring 430 may be moved in adirection toward the bud 440, thereby compressing spring 435 andengaging the adjustment ring 430 with the finger portions 425. This willcause the finger portions 425 to close around the body portion 444 andpotentially some of the second end portion 446 of the bud 440, therebycompressing the body portion 444 and the second end portion 446 andreducing a contact surface of the second end portion 446 of the bud 440.In another exemplary configuration, the adjustment ring 430 may beeither spring-biased in a direction so as to be in engagement with thefinger portions 425 so as to compress the bud 440 and if a larger budsize is desired, the adjustment ring 430 may be moved toward thecontainer 410 to release the finger portions 425 to the extent desired.In yet another exemplary configuration, the adjustment ring 430 may bespring-biased toward the container 410 and out of engagement with thefinger portions 425 so as to render the bud 440 in an uncompressed,larger configuration, and if desired, the adjustment ring 430 may bemoved into engagement with the adjustment fingers 425 by compressing thespring 435 to compress the bud 440. Aside from the operability andconfiguration of the adjustment ring, remaining components of thecryo-surgical system of FIG. 4 are the same as those shown and asdescribed herein with reference to FIGS. 1 and 2 and therefore are notspecifically described herein.

According to the present invention, the exemplary cryo-surgical systemsdescribed herein may also include a plurality of different sized buds toprovide the user with improved flexibility for treating a substantiallylarge range of targeted lesions or treatment areas of lesions. Here, theuser may select the appropriate size bud based upon the approximate sizeof the lesion of targeted treatment area of the lesion.

In addition, the exemplary cryo-surgical system 100 may also includedifferent sized buds to provide with individual delivery tubes 120 tofurther provide

the user with improved flexibility for treating a substantially largerange of targeted lesions or treatment areas of lesions. Here, the usermay select the appropriate delivery tube 120 having the specific sizebud based upon the approximate size of the targeted lesion or treatmentarea of the lesion. Similarly, the contact surface of the second endportion 146 of the bud 140 may have different geometricalconfigurations, such as conical, chisel, or cylindrical geometries.

Furthermore, the delivery tube 120 may be formed not only as a linearcylindrical tube, but may include a curved offset portion or portions toprovide the user with the ability to treat hard-to-reach lesionlocations, such as the back, lower leg, shoulder, etc. For example, thedelivery tube 120 may have a first portion extending along a firstdirection from the container 110 and a second portion or portionsextending along a second direction at an angle from the first direction.Moreover, the delivery tube 120 may have a U-shaped or J-shapedconfiguration. In addition, the delivery tube 120 may be formed havingflexible portions, or flexible along an entire length of the deliverytube 120, to allow the user to shape the delivery tube 120 for easytreatment of lesion locations.

According to the present invention, the bud 140 may be formed of variousmaterials that provide for absorption and flow of the refrigerant fromthe container 110. Here, the bud 140 may be formed of a single material,or may be formed of multiple materials, as detailed above. For example,the first end portion 142, the body portion 144 and the contact surfaceof the second end portion 146 may be formed of a single-density foam.Alternatively, the first end portion 142 may be formed of a firstdensity foam, the body portion 144 may be formed of a second densityfoam, and the contact surface of the second end portion 146 may beformed of a third density foam, wherein each of the first, second, andthird densities may be substantially different. Moreover, the first endportion 142 may be formed of a first density foam, and the body portion144 and the contact surface of the second end portion 146 may be formedof a second density foam, wherein the first and densities may besubstantially different. These configurations may also apply to buds ofthe other exemplary embodiments shown and described herein.

According to the present invention, treatment of a lesion is not limitedto lesions located on exterior surfaces of the body. Specifically, thepresent invention may be used to treat lesions in cavities in the body.Accordingly, an overall length of the delivery tube 120 may be adjustedusing an extendible coupling or mechanism to treat lesions or tissuesdeep inside the human body. Here, the flow of the refrigerant from thecontainer 110 may need to be initiated after the bud 140 is positionedagainst the lesion or tissue to be treated in order to prevent damaginghealthy tissue disposed along the pathway between the lesion or tissueto be treated and the point of entry into the cavity of the deliverytube 120. For, the flow of refrigerant from the container 110 may becommenced once the contact surface of the second end portion 146 of thebud 140 is in proper position to treat the lesion or tissue. Here, arupturing mechanism (not shown) may be incorporated into the first endportion 122 of the delivery tube 120 to allow the user to initiate flowof the refrigerant from within the container 110, through the deliverytube 120, and through the bud 140 to the contact surface of the secondend portion 146 after positioning the bud 140 against the lesion ortissue to be treated. As above, such configurations may apply to theexemplary embodiments and corresponding components of other of theexemplary embodiments shown and described herein.

Although various exemplary embodiments of the present teachings havebeen described as not including a valving mechanism, those havingordinary skill in the art will appreciate that a valving mechanism maybe used if desired with any of the exemplary embodiments of FIGS. 1-4,and may be desirable in situations where a high pressure, flammablerefrigerant in used. FIGS. 5 and 6 depict another exemplary embodimentof a cryosurgical system 500 that utilizes a valving mechanism 575 topermit or stop the flow of the refrigerant from a container 510containing the refrigerant to a delivery tube 520 defining a deliverylumen 521 and ultimately to a bud 540. With reference to the perspectiveview of FIG. 5, the device 500 may be provided with an actuationmechanism 580 configured to be pulled or depressed toward an end of thedevice 500 opposite the bud 540 to place the valving mechanism 575 in anopen position to permit flow of the refrigerant from the container 510through the valving mechanism 575 and into the delivery lumen 521. Thevalving mechanism 575 may be any type of conventional valving mechanismsconfigured to provide such flow control with which those ordinarilyskilled in the art have familiarity. In one exemplary configuration, theactuation member 580 may be locked into the depressed position. However,other configurations contemplate that the actuation member 580 may bespring-biased toward the position closing the valving mechanism 575 andoperated in a manner similar to a trigger-type of valve mechanism onother known containers for dispensing fluids, for example, by a userhaving to continually apply force to the actuation member 580 tomaintain the actuation member 580 in the position that opens the valvingmechanism 575.

Those having skill in the art will also appreciate that in the exemplaryembodiment depicted in FIG. 6, to dispense the fluid from the container510, the container 510 needs to be inverted. However, as thoseordinarily skilled in the art will appreciate, a dip tube could beprovided from the end of the valving mechanism and extending into thecontainer if dispensing of the refrigerant is desired while leaving thecontainer 510 in a non-inverted position (i.e., in the position depictedin FIGS. 5 and 6).

As shown in FIG. 6, the delivery tube 520 may open up into a tube 525 oflarger outer and internal dimensions and that is filled with porousmaterial(s) 550. The porous material(s) 550 may be used in the mannerdescribed for the porous materials 350 described above with reference tothe exemplary embodiments of FIGS. 3A-3C, that is, to store and flowrefrigerant to the bud 540 (e.g., via a wicking type of effect) asrefrigerant evaporates from the bud 540.

Referring now to FIG. 7, another exemplary embodiment of a cryosurgicalsystem 700 is depicted. The system 700 has a similar configuration tothat of FIGS. 5 and 6, (with like parts being labeled with likereference numerals except with a 700 series), with the exception thatthe system 700 includes adjustable finger portions 725 and an adjustmentring 730 that may operate and have a configuration similar to thatdescribed with reference to the exemplary embodiments of FIGS. 1, 2 and4 to adjust the size of the bud 740 and second end portion 746.

The exemplary embodiments of FIGS. 5-7, like those of FIGS. 1-4, can beconfigured as single-use devices. In various exemplary embodiments, thecontainers 510 and 710 may define a volume configured to hold enoughrefrigerant to deliver an amount of refrigerant to sufficiently freeze askin lesion or perform the desired cryo-surgical treatment over adesired time period. For example, the containers 510 and 710 may beconfigured to contain enough refrigerant for a single-use treatment,wherein the amount of refrigerant for the single-use treatment isdependent upon the size, configuration, and material of the bud 540, 740in order to establish a treatment temperature of the bud 540, 740 to beapproximately at least about −27° C., and preferably lower than about−27° C. Depending on the type of refrigerant that is being dispensed, itmay be desirable to use a system that includes a valving mechanism.

Although the present invention has been described in relation toparticular embodiments thereof, many other variations and modificationsand other uses will become apparent to those skilled in the art. Thosehaving ordinary skill in the art will understand that variousmodifications can be made to sizes, materials, arrangements, and typesof parts without departing from the scope of the present teachings.Moreover, although some features described herein may have beendescribed in the context of a particular exemplary embodiment, thoseordinarily skilled in the art will appreciate that various features ofdifferent exemplary embodiments may be combined with other exemplaryembodiments. It is intended therefore, that the present teachings belimited not by the specific disclosure herein and that the claims beentitled to their full scope, including equivalents.

What is claimed is:
 1. A method of preparing a cryo-surgical system, themethod comprising: accessing a container containing a refrigerant and adelivery tube having a first end configured to be in flow communicationwith the container and a second end opposite the first end and includinga plurality of flexible finger portions disposed proximate the secondend of the delivery tube opposite the first end; providing a porousapplicator bud disposed proximate the second end of the delivery tube,the porous applicator bud having a body portion disposed between theplurality of flexible finger portions and a contact surface extendingfrom the plurality of flexible finger portions; and adjusting a size ofthe porous applicator bud by at least partially removing compressionforces from the porous applicator bud to increase the size of a contactsurface of the porous applicator bud or engaging the plurality offlexible finger portions and thereby compressing the contact surface ofthe porous applicator bud.
 2. A method of claim 1 further comprising:delivering refrigerant from the container to the porous applicator bud;and applying the porous applicator bud to a targeted treatment lesionarea to freeze the lesion area.
 3. A method according to claim 1,wherein delivering the refrigerant from the container to the porousapplicator bud includes flowing the refrigerant from the container tothe porous applicator bud via the delivery tube.
 4. A method accordingto claim 1, wherein delivering the refrigerant from the container to theporous applicator bud includes delivering the refrigerant from thecontainer to the porous applicator bud without using a valvingmechanism.
 5. A method according to claim 1, wherein delivering therefrigerant from the container to the porous applicator bud includesstoring the refrigerant from the container in a porous material andsupplying the stored refrigerant from the porous material to the porousapplicator bud.
 6. A method according to claim 1, further comprising:coupling the delivery tube to the container to place a lumen of thedelivery tube in flow communication with the refrigerant in thecontainer.
 7. A method according to claim 6, wherein coupling thedelivery tube to the container includes penetrating a sealing member onthe container.
 8. A method according to claim 1 further comprising:coupling the first end of the delivery tube directly to the containerwithout an intervening valve device therebetween.
 9. A method accordingto claim 1, wherein adjusting the size of the porous applicator budincludes engaging an adjustment ring with the plurality of flexiblefinger portions.
 10. A method according to claim 9, wherein theadjustment ring is disposed along the delivery tube adjacent to theplurality of flexible finger portions.
 11. A method of claim 9, whereinengaging the adjustment ring includes loosening the adjustment ring toat least partially remove compression forces from the porous applicatorbud to increase the size of the contact surface of the porous applicatorbud or tightening the adjustment ring to compress the contact surface ofthe porous applicator bud.
 12. A method according to claim 9, whereinengaging the adjustment ring with the plurality of flexible fingerportions includes engaging a threaded portion of the adjustment ringwith a threaded portion of the delivery tube.
 13. A method according toclaim 9, wherein the adjustment ring is engaged by a spring-biasedmovement relative to the plurality of flexible finger portions.